Position Summary

The Senior Manager, Technical Operations will provide phase appropriate CMC GMP support for Odonate’s drug candidates. This position will serve as a CMC/Technical Operations representative for selected programs. This position will support the transition of internally developed manufacturing processes to contract manufacturing partners inclusive of scale up and process validation at contract manufacturing sites.

Essential Duties and Responsibilities

  • Work closely and collaboratively with Odonate’s internal development team and external drug product related manufacturing partners to define, optimize and scale GMP manufacturing processes
  • Collaborate and approve CMO master batch records, perform CMC review of executed of batch records for drug product and packaging/labeling
  • Work with CMC stability and analytical to assure drug product release test and stability programs are in place to support IND and NDA filings
  • Author and review technical reports, SOPs, validation protocols and regulatory sections of cGMP related documents

Qualifications

  • Bachelor’s Degree in Chemistry or related science required
  • Minimum 5 years of progressive experience working in a cGMP pharmaceutical environment required
  • Experience working with third-party formulation development, drug product manufacturing and clinical/commercial packaging vendors
  • Must have experience with CMC writing and competent regulatory filing requirements
  • Knowledge of analytical method validation and manufacturing process validation
  • Previous experience in drug product formulation of tablets and capsules
  • Experience with small molecule product development preferred
  • Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines
  • Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences
  • Comfortable working in a virtual bio-pharmaceutical organization with multiple global third-party providers
  • Must be willing and able to travel domestically and/or internationally up to 20%

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